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Safety and Efficacy Study of rEV131 in the Treatment of Ocular Inflammation After Cataract Surgery

NCT ID: NCT00353964

Last Updated: 2006-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to evaluate the safety and effectiveness of three concentrations of rEV131, a new investigational anti-inflammatory agent, compared to placebo (an inactive substance) and an FDA approved anti-inflammatory agent in patients with ocular inflammation who have undergone cataract extraction with intra-ocular lens implantation.

Detailed Description

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Conditions

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Ocular Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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rEV131

Intervention Type DRUG

Prenisolone sodium phosphate 1.0%

Intervention Type DRUG

rEV131 vehicle

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* be male or female who has undergone unilateral cataract extraction by phacoemulsification (PHACO) method with implantation of a posterior chamber intraocular lens

Exclusion Criteria

* have unstable glaucoma
* have an active bacterial and/or viral infection
* use any ocular or systemic anti-inflammatory agents within 1 week prior to enrollment and for the duration of the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Evolutec Group

INDUSTRY

Sponsor Role lead

Principal Investigators

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Wynne Weston-Davies, MD

Role: STUDY_DIRECTOR

Evolutec Group

Locations

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ORA Study Sites

North Andover, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Susan French, ORA Clinical Research & Development Inc.

Role: CONTACT

Phone: 978-685-8900

Email: [email protected]

Facility Contacts

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ORA Site Support Center

Role: primary

Other Identifiers

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EVOL-PRO-06-024

Identifier Type: -

Identifier Source: org_study_id